FDA Guidance for Industry concerning Wholesale Distributor Verification Requirement for Saleable Returned Drug Products published

Recommendation

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The U.S. Food and Drug Administration (FDA) has published the final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies".

On September 24, 2019, the FDA has published the "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy guidance". This Guidance is part of FDA's Drug Supply Chain Security Act (DSCSA). Beginning November 27, 2019, wholesale distributors were required to verify the product identifier, including the standardized numerical identifier, on each sealed homogeneous case of saleable returned product, or, if such product is not in a sealed homogeneous case, on each package of saleable returned product, prior to further distributing such returned product. In the 2019 Compliance Policy, a 1-year delay in enforcement of the requirement was announced, meaning a delay in enforcement of this requirement until November 27, 2020.

The FDA now stated that since the announcement of the 2019 Compliance Policy, comments and feedback from wholesale distributors and other trading partners and stakeholders were received, expressing concern with industry-wide readiness for implementation of the requierements. It was pointed out that due to the large volume of saleable returned product, wholesale distributors still need more time to test verification systems using real-time volumes of saleable returned product with all trading partners involved. Wholesale distributors also pointed out significant delays in testing these verification systems due to the competing priority of responding to COVID-19.

The FDA came to the conclusion, that wholesale distributors may need additional time beyond November 27, 2020: "FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under the DSCSA (Title II of Pub. L. 113-54). This represents an additional 3-year delay from the delay set forth in the 2019 Compliance Policy in enforcement of the requirement for wholesale distributors to verify the product identifier prior to further distributing that returned product. In addition, FDA does not intend to take action against dispensers who do not verify the statutorily-designated portion of product identifiers of suspect or illegitimate product before November 27, 2023. This policy represents a 3-year delay in enforcement of the requirements for dispensers to verify the product identifier when investigating suspect or illegitimate product."

For more information and to download the final guidance document, please visit the FDA website.